Subcoated simulated capsule-like medicament

ABSTRACT

A simulated capsule-like medicament comprising a subcoating of a mixture of a water-soluble, film-forming polymer, e.g. hydroxypropylmethyl cellulose and a hydrophobic plasticizer e.g. castor oil, which promotes a smooth uniform and substantially bubble free outer coating, e.g. gelatin, for the capsule-like medicament; capsule-like medicaments which are slightly bowed in shape; and a process of making such medicaments.

This is a continuation of application Ser. No. 07/784,623, filed Oct.31, 1991, now U.S. Pat. No. 5,658,589 which is a continuation-in-part ofapplication Ser. No. 07/345,599, filed Apr. 28, 1989, now abandoned, ofwhich are all hereby incorporated by reference.

FIELD OF THE INVENTION

This invention relates to subcoated simulated capsule-like medicaments.More particularly this invention relates to a solid medicament capletcore which has been subcoated with a mixture of a water-soluble,film-forming polymer and a hydrophobic plasticizer and coated with asmooth outer coating to provide the appearance of a capsule-likemedicament and a process of making such coated medicaments.

BACKGROUND OF THE INVENTION

Filled two-piece gelatin capsules for the encapsulation of variousmedicinal agents have been used for administering drugs since themid-19th century. This capsule form of medicament proved to be verypopular because hard gelatin capsules are tasteless, easily administeredand easily filled either at a pharmacy or pre-filled in large quantitiesat commercial plants. While hard shell gelatin capsules are stillpopular dosage forms for pharmacist dispensed medicaments they havegenerally been discontinued in many over-the-counter products because ofthe risk of tampering with their contents.

Absent the susceptibility of capsule form medicaments to tamperings thecapsule form was extremely popular with consumers because of a number ofadvantages. Many consumers prefer the gelatin form of capsule because ofthe perceived efficacy, taste, feel and swallowability of the gelatincapsule form of medicament.

This consumer preference for gelatin capsule-like medicaments provided achallenge to the industry to produce capsule-like medicaments which aretamper-proof yet provide the consumer with the advantages of a hardshell gelatin capsule-like dosage form Norbert I. Berta developedsimulated capsule-like medicaments and a process for making suchcapsule-like medicaments as disclosed in his U.S. Pat. No. 4,820,524.The entire disclosure of this issued U.S. patent is hereby incorporatedherein by reference. Norbert I. Berta has also developed variations ofthe processes for making simulated capsule-like medicaments andapparatus for producing such medicaments as disclosed in co-pending U.S.patent application Ser. No. 129,108 filed Dec. 4, 1987, now U.S. Pat.No. 4,921,108; 129,109 filed Dec. 4, 1987, now U.S. Pat. No. 4,867,903;190,551 filed May 5, 1988, now U.S. Pat. No. 4,966,771; and 190,616filed May 5, 1988, now U.S. Pat. No. 5,314,537. The simulatedcapsule-like medicaments developed by Berta were responsive to a longfelt need in the industry to provide a simulated substitute for thepopular dosage form of gelatin capsules. While gelatin coating ofuncoated compressed medicaments such as acetaminophen is possible inaccordance with the invention of Berta, it is difficult to control thequality of the surface appearance of such gelatin-coated caplets.

Beyond the development of a simulated capsule-like medicament severalfactors and considerations must be met to commercially produce a capsulewhich has a smooth, uniform and substantially bubble free outer coatingappearance. A preferred gelatin-coated caplet is one in which twodistinctly colored gelatin coating solutions are utilized to produce abi-colored gelatin-coated caplet. The two overlapping distinctly coloredgelatin coatings form a seam about the transverse axis of themedicament. The presence of this seam and the distinct bi-coloringcontributes to the consumer's perception of these simulated capsule-likemedicaments as equivalents to gelatin capsule dosage forms.

The gelatin coated caplet product must adequately simulate acapsule-like medicament from a consumer's sight and touch perspectiveand must therefore be absent of discoloration, pits and gouges. Thepresence of such physical imperfections may erode the consumerIsperception as to the gelatin coated caplet's capsule-like nature and thetamper-free nature of this dosage form. Strong consumer confidence inthe gelatin capsule-like nature and tamper-resistance of the simulatedcapsule medicament of the invention is of the utmost importance in themarketing of this dosage form and forms an object of the presentinvention. It is therefore an object of the present invention to providea subcoating for a solid caplet medicament core which minimizes bubbleformation, discoloration and other aesthetic imperfections to providefor a smooth, uniform and substantially bubble free outer coatingappearance to simulated capsule-like medicaments.

SUMMARY OF THE INVENTION

The foregoing object of providing a simulated capsule-like medicamentwhich has a smooth, uniform and substantially bubble free outer coatingappearance has now been accomplished in accordance with the compositionsand process of the present invention.

In accordance with the purposes of the invention, as embodied and fullydescribed herein, the invention comprises a simulated capsule-likemedicament comprising: a solid caplet core comprising a medicament; asubcoating composition on the caplet core comprising a mixture of awater-soluble, film-forming polymer and a hydrophobic plasticizer; and asmooth outer coating whereby the subcoating composition promotes asmooth, uniform and substantially bubble free outer coating appearanceto the capsule-like medicament.

In another embodiment of the present invention, there is provided aswallowable solid core having a smooth, uniform and substantially bubblefree outer coating comprising a solid core containing a medicament whichhas an exterior surface that is coated with a subcoating composed of amixture of a water-soluble, film-forming polymer selected from the groupconsisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose,mixtures of hydroxypropyl cellulose and hydroxypropylmethyl cellulose,mixtures of hydroxypropyl cellulose and methyl cellulose wherein thehydroxypropyl cellulose constitutes greater than 50 weight percent butless than 100 weight percent of the mixture of hydroxypropyl celluloseand methyl cellulose, mixtures of hydroxypropyl cellulose andhydroxyethyl cellulose wherein the hydroxypropyl cellulose constitutesgreater than 80 weight percent but less than 100 weight percent of themixture of hydroxypropyl cellulose and hydroxyethyl cellulose, mixturesof hydroxypropylmethyl cellulose and methyl cellulose wherein thehydroxypropylmethyl cellulose constitutes greater than 50 weight percentbut less than 100 weight percent of the mixture of hydroxypropylmethylcellulose and methyl cellulose, mixtures of hydroxypropylmethylcellulose and hydroxyethyl cellulose wherein the hydroxypropylmethylcellulose constitutes more than 80 weight percent but less than 100weight percent of the mixture of hydroxypropylmethyl cellulose andhydroxyethyl cellulose and combinations of two or more thereof; andcastor oil, wherein the subcoating provides an outer subsurface which iscoated with a gelatinous coating, wherein the subcoating is provided inan amount which is effective to promote a smooth, uniform andsubstantially bubble-free outer coating appearance to capsule-likemedicaments.

In preferred embodiments of the invention the water-soluble,film-forming polymer is hydroxypropyl-methylcellulose, the hydrophobicplasticizer comprises castor oil and the smooth outer coatingcomposition is gelatin . In more preferred embodiments, thehydroxypropyl-methylcellulose and castor oil comprise from about 2 toabout 8%, more preferably about 4 to about 6%, and most preferably about4% by weight of the total weight of the subcoated caplet core.

In further preferred embodiments of the invention the medicamentcomprises a composition selected from the group consisting ofacetaminophen, ibuprofen, loperamide, naproxene pseudoephedrine,dextromethorphan, chlorphenarimine, and mixtures thereof.

In further preferred embodiments a solid caplet core of the capsule-likemedicament has a slight convex bowed shape. Preferably, the bowrepresents an arcuate variance of about 1 to 5 degrees about alongitudinal axis of the caplet core.

As embodied and broadly described herein the invention further comprisesa process for preparing a simulated capsule-like medicament comprisingthe steps of: compressing a mixture of a medicament and pharmaceuticallyacceptable excipients to form a solid caplet core; applying a subcoatingcomposition comprising a mixture of a water-soluble, film-formingpolymer and a hydrophobic plasticizer to the solid caplet core; andapplying a smooth outer coating to the subcoated caplet core to providea smooth, uniform and substantially bubble free outer coating appearanceto the capsule-like medicament. The preferred components for the capletcore and the subcoating mixture are as described above. In preferredembodiments of the process of the invention the outer coating is gelatinand is applied at a temperature of from about 35 to 55° C., preferablyat about 40 to 50° C.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front-top perspective view of a caplet core of theinvention;

FIG. 2 is a top plan view of the caplet core;

FIG. 3 is a side elevational view of the caplet core;

FIG. 4 is a front elevational view of the caplet core; and,

FIG. 5 is a top plan view of a caplet of the prior art.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

Reference will now be made in detail to preferred embodiments of theinvention, examples of which are illustrated in the following examplessection.

The present invention provides a subcoating which is suitable forcoating any swallowable solid core which will be subsequently coatedwith a gelatinous outer layer. The solid core may be of any shape whichis suitable for the oral administration of drug substances including butnot limited to tablet or capsule shapes. Suitable method ofmanufacturing solid cores are well known in the art such as thetechniques on pages 1576-1607 of Remington's Pharmaceutical Sciences,Mack Publishing Company (Fifteenth edition) 1975 the text of which ishereby incorporated by reference. Currently the preferred solid coreshapes for subcoating are solid core capsule-like shapes hereinafterreferred to as caplets.

To achieve one of the object of the invention which is to provide asimulated capsule-like medicament which has a smooth, uniform andsubstantially bubble-free outer coating appearance, a subcoating isapplied to the solid caplet medicament core to provide a compatiblecoating surface for the gelatinous coating. The subcoating compositionin accordance with the invention provides a surface for gelatinouscoating that minimizes bubble formation, discoloration and otheraesthetic imperfections

The capsule-like medicament of the invention comprises a solid capletcore of a medicament which can be compressed into a caplet coreutilizing conventional excipients and tableting aids. Any pharmaceuticalactive or medicament that is capable of being formed into a caplet core,may be used in accordance with the invention. Examples of suitablemedicaments which may be utilized in accordance with the inventioninclude, but are not limited to, acetaminophen, ibuprofen, loperamide,naproxen, pseudoephedrine, dextromethorphan, chlorphenarimine, andmixtures thereof. These medicaments may be used alone or in combinationsuch as a sinus headache combination comprising for example,acetaminophen and pseudoephedrine.

The subcoating composition of the present invention was developed toprovide multiple functions required for a suitable subcoat. Thesefunctions and characteristics of the subcoat or pre-coat include thefollowing: adequate film strength of the subcoating to allow thesubcoated tablet to withstand mechanical transfer and maintain theintegrity of the subcoat; compatibility of the subcoat material with themedicament to be coated; compatibility of the subcoat material with thesmooth outer coating such that adequate pick-up of the smooth outercoating is achieved with a minimum of bubble formation on the finalproduct; and compatibility of the subcoat material with the outercoating such that the subcoat does not adversely affect the color of theouter coating composition particularly where two distinct colors areutilized.

The subcoating composition of the invention also provides advantageousprocessing functions. The subcoating helps eliminate dust and otherdegradation of the medicament caplet core. The subcoating also preventscontamination of the gelatin coating solution by the medicament presentby providing a full separation barrier between the gelatin coatingsolution and the medicament in the subcoated solid caplet core.

In accordance with the present invention, it was found that a subcoatingcomposition which accomplishes the required functions comprises amixture of a water-soluble, film-forming polymer and a hydrophobicplasticizer.

One suitable group of water-soluble film-forming polymers are cellulosederivatives selected from the group consisting of hydroxypropylmethylcellulose (hereinafter also referred to as HPHC) and hydroxypropylcellulose (hereinafter also referred to as HPC) which may be usedindividually or combined in mixtures. Hydroxypropylmethyl cellulose andhdyroxypropyl cellulose may also be combined with other cellulosederivatives such as methyl cellulose and hydroxyethyl cellulose. Theamount of HPHC and/or HPC present in mixtures with methyl celluloseshould be in the range of from about 50 weight percent to less than 100weight percent of HPHC and/or HPC based on the dry weight of thecomponents equalling 100 weight percent. The amount of HPMC and/or HPCpresent in mixtures with hydroxyethyl cellulose should be in the rangeof from about 80 mole percent to less than 100 weight percent of HPMCand/or HPC present in the mixture based on the dry weight of thecomponents of the mixture equalling 100 weight percent. The molecularweight of the water-soluble film- forming polymers utilized in thepresent invention is not believed to be critical to the practice of thepresent invention. It is however recommended that the average molecularweight of the water-soluble film-forming polymer be in the range of fromabout 50,000 to 150,000. Suitable grades of hydroxypropylmethylcellulose polymers within these weight ranges may be obtained from DowChemical Company designated as E50 and E150. Currently preferredwater-soluble film forming polymers are hydroxypropylmethyl cellulosepolymers having a molecular weight of about 50,000. The degree ofsubstitution of the cellulose derivative utilized in the subcoatingshould conform to the degree of substitution approved for this use bythe FDA. For example the degree of substitution of HPMC should be in therange of from 19-30 percent methoxyl substitution and from 4-12 percentpropyl substitution and preferably in the range of from 28-30 methoxylpercent and 7-12 percent propyl. Methyl cellulose should be substitutedin the range of from 27.5-31.5 percent methoxy groups. The currentlypreferred hydrophobic plasticizer is castor oil. The amount ofsubcoating composition utilized should be an amount effective to providethe above-mentioned desirable functions and characteristics of thesubcoated caplet core.

Optimization of the coating amount will vary in accordance with the sizeof the caplet core and particular medicaments utilized. Preferably, amixture of the water-soluble film forming polymer (for example thepreferred hydroxypropylmethyl cellulose) and castor oil comprises fromabout 2 to about 8%, more preferably about 4 to about 6% and mostpreferably about 4% by weight of the total weight of the subcoatedcaplet core. The amount of castor oil present as a hydrophobicplasticizer comprises from about 0.1 to about 1% by weight of the totalweight of the subcoated caplet core. Preferably the amount ofwater-soluble film-forming polymer e.g. hydroxypropylmethyl cellulose,to the hydrophobic plasticizer e.g. castor oil, is on the order of about20.1.

It is important that the outer coating of the simulated capsule-likemedicament be smooth, uniform and substantially bubble free to providethe perception of a capsule-like medicament. To achieve superiorsimulation of gelatin capsule dosage forms it is preferred to use a dualcolor outer coating which meets at a distinct seam at about the middleof the coated medicament caplet. The preferred outer coating compositionis gelatin whereby the subcoated caplet core is dipped into a gelatinoussolution. More preferably opposite ends of a subcoated medicament capletcore are dipped into two gelatinous solutions of distinct color toproduce a dual colored capsule-like medicament. The amount of gelatinouscoating added to the product is dependent upon the outer appearancedesired for the product. Generally, enough gelatinous coating must beadded on to the caplet to provide a smooth uniform and bubble free outercoating appearance and provide a gelatinous feel to the touch and in themouth of consumers swallowing the simulated capsule-like medicament. Apreferred gelatinous coating add-on is about 6.0 to about 8.3% by weightof the total weight of the simulated capsule-like medicament.

It is also recommended that the gelatin coating utilized in the presentinvention for coating the caplet surface be provided in an aqueoussolution having a gelatin concentration of from in the range of about 20weight percent to about 40 weight percent gelatin. The apparentviscosity of this gelatin solution is recommended to be in the range offrom about 800 to about 1000 cps as measured at about 40°C.-50° C.temperature on a Brookfield viscometer. The preferred gelatin for thepractice of the present invention is a mixture of in the range of fromabout 60 weight percent to about 80 weight percent of bone gelatin andin the range of about 40 weight percent to about 20 weight percent ofpork gelatin on a dry weight basis with the total weight percent of thedry components totalling 100 weight percent. The currently preferredgelatin mixture is 70 weight percent bone gelatin and 30 weight percentpork gelatin.

In preferred embodiments the capsule-like medicament of the inventionhas a caplet core which has a slight convex bowed shape. This shape isillustrated in FIGS. 1-4 herein which are described in more detailbelow. This bowed shape serves two important functions. It was foundthat caplets of the prior art that were unbowed or had straight edgeswere more prone to stick to each other and form "twins." Formation oftwins or twinning is the joining of one or more caplets together duringprocessing along edges in contact with each other. Further, caplets withstraight edges also tend to stick or twin together temporarily and causesurface imperfections, e.g. pitting and/or gouging. Twinning of straightedged prior art caplets is illustrated in FIG. 5 herein, which isdescribed in more detail below.

Twinning of caplets can apply to any situation where the caplet coreshave a tacky or sticky outer coating due to the nature of theingredients comprising the medicament or those comprising the subcoatingor gelatinous outer coating of the caplets. For example, coatings suchas shellac, seal coatings, or sugar coatings also provide tacky capletswhich are prone to form twins. It is therefore advantageous in preparingsimulated capsule-like medicaments in accordance with the presentinvention, as well as, the handling of all tacky caplet cores to utilizecaplets which have a slight bowed shape which reduces twinning ofcaplets due to contact during processing. The bowed shape minimizes thepoint of contact between caplets and thus reduces sticking or twinningof caplets to each other.

In preferred embodiments of the present invention the bowing is a convexbow that stems from the middle of a longitudinal axis of the caplet coreoutwards toward the two ends. The bowed variance along the longitudinalaxis of the caplet core is on the order of about 1 to 5 degrees. Thisarcuate variance is great enough to reduce the twinning of the capletsduring processing without detracting from the capsule-like shape andappearance of the final medicament product which is important to itssimulation of a gelatin capsule.

Another surprising advantage of providing caplets with a slightly convexbowed shape is that the shape provides an increase in tablet hardness ofup to about 10% as compared with regular unbowed caplet shaped cores.The increase in hardness may be due to some degree to the increasedthickness of the caplet about the center area but the magnitude ofincrease achieved could not be anticipated by this slight change inthickness at this area. It has also been found advantageous to provide aconvex bow shaped caplet since the increased hardness contributes topreventing surface pitting and breaking of the cores during the coatingprocess.

The bow shaped caplet core of the invention will now be described withreference to the Figures herein. FIG. 1 is a perspective view of acaplet core (1) from the top (3), front (5) and right (7) sides. Aperipheral edge surface or "belly band" (9) extends longitudinallyaround the side of the caplet core (1). FIG. 2 shows a top plan view ofthe caplet core (1) with adjacent caplet cores (11) shown in brokenlines on either side of the caplet core (1) at their belly bands (9) and(13). In accordance with the slight bowed shape of the belly bands (9)and (13) the adjacent caplet cores have only a single point of contact(15) with each other along the arcuate edge surface of the belly band.The amount of bowing need only be slight on the order of 1 to 5 degreesas is illustrated by angle V in the drawing. FIG. 3 is a sideelevational view of the caplet core (1) and belly band (9). FIG. 4 is afront elevational view of the caplet core (1) and belly band (9).

FIG. 5 is a view similar to FIG. 2 showing a straight edged or unbowedcaplet core (50) of the prior art with adjacent or twinned caplet cores(52) in contact therewith along straight edged belly bands (54) with apoint of contact along the entire straight edge of the caplet core asillustrated by the dimension (56) marked out by length indicators (58)and (60). This large potential area of contact along the entire straightedge (56) of caplet cores of the prior art encourages sticking ortwinning of caplets to each other and production of surface imperfect ortwinned caplets which are not suitable for further commercial use assimulated capsule-like medicaments.

In accordance with the present invention, a process is also provided forpreparing simulated capsule-like medicaments. The process comprises thesteps of compressing a mixture of medicament and compatible excipientsto form a solid caplet core. The excipients chosen and the compressionapplied should be adequate to provide a caplet with sufficient hardnessfor prevention of surface pitting and caplet breakage during coating ofthe caplet core. For capsule-like acetaminophen medicaments thepreferred hardness is about 10-14 Kp and more preferably about 10-11 Kp.

To provide a capsule shape appearance the width to thickness ratio aboutthe simulated capsule-like medicament should be as close as possible toone. Gelatin capsule dosage forms are generally round in shape andtherefore have a width to thickness ratio by definition of one. Apreferred tooling dimension which gives this appearance is 0.750 inchesby 0.250 inches by 0.075 inches. The thickness resulting from thistooling is 0.244 inches. These dimensions may vary as the size of thecaplet varies but efforts should be made to keep the width to thicknessratios as close as possible to one to provide adequate simulation of agelatin capsule dosage form.

The subcoating composition, preferably a mixture of hydroxypropylmethylcellulose and castor oils is applied from an 8% weight by weight aqueoussolution. Acceptable subcoatings can be applied with subcoatingsolutions of from 6 to 8% concentration but 8% is preferred since ashorter amount of spraying time is required to provide the desiredamount of subcoating on the caplet core. Coating levels above 8% werefound to provide less desirable subcoatings because of unevenness ofapplication of the subcoating composition. The concentration of thesubcoating solution is not considered critical to the coating process.The caplet cores are subcoated to preferably provide about 2 to 8%, morepreferably about 4 to 6 and most preferably about 4% subcoating byweight of the total weight of the subcoated caplet core.

A smooth outer coating is applied to the subcoated caplet core toprovide a smooth, uniform and substantially bubble free outer coatingappearance to the capsule-like medicament. The preferred outer coatingis a gelatin outer coating and more preferably a bicolor gelatincoating. Application of the gelatinous coating is by dipping of thesubcoated caplet core into a gelatin solution which has a temperature inthe range of about 35-55° C., preferably about 40 to 50° C. Highergelatin solution temperatures generally result in a lower viscosity ofthe gelatin solution. The gelatin solution temperature is varied toadjust the viscosity and gelatin pick-up on the subcoated caplet.

Gelatin dipping may be performed by any adequate means including handdipping of the caplets into a gelatin solution. A particularly preferredmethod is performed in accordance with the teachings of Berta in theaforementioned U.S. Pat. Nos. 4,820,524 which has been incorporatedherein by reference. This patent provides a useful process for providingbi-color gelatin coated capsule-like medicaments which have a slightlyraised seam about the color overlapping portion of the caplet whichcontributes to its simulated capsule-like feel and appearance. Any colorgelatin solutions may be utilized, but it is preferred that the colorsbe distinct.

EXAMPLE

The invention will now be illustrated by example. The example is notintended to be limiting of the scope of the present invention but readin conjunction with the detailed and general description above providefurther understanding of the present invention and an outline of aprocess for preparing the compositions of the invention.

Example 1

Simulated Capsule-like Acetaminophen Dosage Form

An acetaminophen caplet core was prepared from the following components:

    ______________________________________                        Mg/Caplet    ______________________________________    I. - Active and Excipients    acetaminophen, USP    500.0       mg    powdered cellulose, NF                          40.0        mg    pregelatinized starch, NF                          10.0        mg    sodium starch glycolate, NF                          10.0        mg    II. - Granulating Agent    starch, NF            40.0        mg    purified water, USP   q.s.    III - Dry Adds    magnesium stearate, NF                          3.20        mg    Total                 603.2       mg    ______________________________________

Working Directions

A. Weigh the desired components of Part I in the proportions providedand add them to a bowl of a fluid bed granulator such as an AEROKATICbrand granulator

B. Prepare the granulating agent (Part II) by adding the purified waterto a processing tank with approximately 15 grams of water for each gramof starch NF. Slowly mix in the starch and heat the mixture until thetemperature reaches about 82-84° C.

C. With the components of Part I in a heated fluidized state and aninlet air temperature of 75-85° C., spray the granulating agent onto thepowders.

D. After all the granulating agent has been sprayed, dry the granulatedpowders to a moisture content of about 1.4 to 1.9% as determined by losson drying using for example a COMPUTRAC brand analyzer.

E. Sieve the dried granulation, for example, using a GLATT QUICK brandsieve stator No. 3, screen No. 1.5 mm, 1,000 RPM.

F. Blend the sieved and dried granulation with the powders of Part IIIusing a suitable mixer such as a twin shell, ribbon or planetary mixer.

G. Load the granulation into a tableting machine and compress thecaplets using a capsule-shaped tooling device of the dimensions0.750"×0.250"×0.075". The thickness resulting from this tooling is0.244". Ideal caplet hardness is about 10 Kp.

H. Coat the compressed solid caplet cores of step G by spraying with an8% aqueous solution which comprises a mixture of hydroxypropylmethylcellulose and castor oil in a ratio of about 20:1 (this mixture iscommercially available from Colorcon as Opadry YS-5-7042). Thesubcoating solution is applied utilizing a Accla-Cota perforated pancoating unit manufactured by Thomas Engineering (Hoffman Estates, Ill.)to achieve a 4% subcoating by weight of the total weight of thesubcoated caplet core.

Gelatin Dipping

The subcoated caplet core is then subjected to gelatin dipping. Thegelatin used is preferred to be a mixture of 70 weight percent bone and30 weight percent pork gelatin which may be obtained separately fromKind and Knox. The gelatin solution for dipping was a 30 weight percentaqueous solution with an apparent viscosity of about 800-1,000 cps asmeasured at 40° C. by a Brookfield viscometer. The gelatin dipping maybe accomplished by hand e.g. by dipping half of the subcoated capletcore into a yellow gelatin solution at about 40° C. for about 6 secondsand withdrawing the half coated caplet and allowing it to dry beforedipping the as yet non-gelatin coated half of the caplet into a redgelatin solution at a temperature of 40° C. for about 6 seconds. Wherebya slight overlapping of the two distinctly colored gelatinous cores isachieved about the midway portion of the caplet.

The caplet may also be gel dipped in accordance with the process andapparatus as described in U.S. Pat. No. 4,820,524 of Berta which hasbeen incorporated herein by reference.

The scope of the present invention is not limited by the description,examples and suggested uses herein and modifications can be made withoutdeparting from the spirit of the invention. For example, othercomponents may be added to the caplet core including various flavorings,preservatives and other pharmaceutical excipients. The present inventionmay also be provided in a sustained release formulation wherein thecaplet core comprises a medicament and sustained release promotingexcipients. The simulated capsule-like compositions and slightly bowedcaplets may also be applicable to non-medicinal applications such asoral dosage forms of vitamins and/or other nutrients.

Application of the compositions and processes of the present inventionfor medical and pharmaceutical uses can be accomplished by clinical,medical and pharmaceutical methods and techniques as are presently orprospectively known to those skilled in the art. Thus it is intendedthat the present invention cover the modifications and variations ofthis invention provided that they come within the scope of the appendedclaims and their equivalents.

What is claimed is:
 1. A caplet comprising a caplet core containing apharmaceutical active, said core having longitudinal sides and saidsides each having a peripheral edge surface that is bowed in shape. 2.The caplet of claim 1 wherein the bowed shape is convex and represents avariance of about 1 to 5 degrees about a longitudinal axis of the capletcore.